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  • OTC combination drug with APAP-IBU, not approved again
  • by Lee, Tak-Sun | translator Choi HeeYoung | Jun 11, 2021 05:53am
Last year, it applied for FDA-based approval, but the Central Pharmaceutical Affairs Review Committee refused
7 out of 10 members opposed because the safety issue was not resolved
 ¡ã Advil Dual Action in US
OTC approval of APAP-IBU complex has failed again. Experts who participated in the review objected to the permission on the grounds that safety issues had not been resolved.

According to the Central Pharmaceutical Affairs Review Committee minutes released on the 7th, seven out of 10 members opposed the OTC approval of Acetaminophen-Ibuprofen.

The MFDS is also known to have opposed it, and finally, the complex failed to make its second attempt at licensing after 2017. Based on UK permit in 2017, this time it applied for permit based on US FDA. The complex requested in 2017 was a product that take one or two tablets of Acetaminophen 500mg-Ibuprofen, and it applied for permission to take two tablets of Acetaminophe
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